is being presented by Dr. Nermeen Varawalla, CEO, of ECCRO and airs on Tuesday, April 17th, 2012. For more details or to register, please visit our site at www.fxconferences.com
The value of emerging countries in delivering cost-effective patient recruitment is well documented. However concerns remain about data quality, GCP compliance, extrapolation of trial outcomes and regulatory hurdles. These concerns often can be addressed by combining an understanding of international clinical trial requirements and local expertise.
Our speaker for this event is Dr. Nermeen Varawalla, a reknowned expert on the conduct of clinical studies in emerging markets in general, and India in particular. In this presentation she discusses how to take things one step further by customizing industry best practices for the emerging clinical trial environment. These include the formation of select investigator networks, integrated site management and data-driven, hybrid monitoring. In this presentation, Dr. Varawalla shares case studies highlighting her work in India to illustrate the effectiveness of these practices in overcoming typical concerns about conducting clinical research in emerging countries.
Showing posts with label clinical trial. Show all posts
Showing posts with label clinical trial. Show all posts
Tuesday, April 3, 2012
Friday, March 9, 2012
Improving Study Feasibility- Why Sites Fail and How to Avoid It
is being presented by Nikki Christison, President, of Clinical Resolutions and airs on Wednesday, March 14th, 2012. For more details or to register, please visit our site at www.fxconferences.com
Only 7% of selected sites meet their enrollment targets. Millions of dollars are spent rescuing studies through amendments, adding more sites, and increasing advertising funds. The simple fix would be to select the “right” sites; however, if it was that easy everyone would be doing it.
Site selection should be viewed as a two-way street, with both sponsors and sites taking ownership for the process. Sponsors often provide limited information to sites during the selection process, and then establish unrealistic expectations once the sites agree to do the study. Meantime, sites are eager to get studies to support their patients, reputations and budgets, but are also afraid to say “no” in case they miss out on a future opportunity.
This audio conference presentation looks at the root causes of feasibility assessment failures, discussing the responsibilities of sites and sponsors during the feasibility process, and providing recommendations for “fixing” the feasibility assessment process for both the sponsor and site.
Only 7% of selected sites meet their enrollment targets. Millions of dollars are spent rescuing studies through amendments, adding more sites, and increasing advertising funds. The simple fix would be to select the “right” sites; however, if it was that easy everyone would be doing it.
Site selection should be viewed as a two-way street, with both sponsors and sites taking ownership for the process. Sponsors often provide limited information to sites during the selection process, and then establish unrealistic expectations once the sites agree to do the study. Meantime, sites are eager to get studies to support their patients, reputations and budgets, but are also afraid to say “no” in case they miss out on a future opportunity.
This audio conference presentation looks at the root causes of feasibility assessment failures, discussing the responsibilities of sites and sponsors during the feasibility process, and providing recommendations for “fixing” the feasibility assessment process for both the sponsor and site.
Tuesday, January 24, 2012
Patient Recruitment: How It's Broken and Five Ways to Fix It
is being presented by Sherry Reuter, President, of Sherry Reuter & Associates and airs on Wednesday, February 8th, 2012. For more details, or to register please visit our site at www.fxconferences.com
The numbers don't lie: clinical trial enrollment rates have dropped from 75% in 2000 to 59% in 2006 and retention rates have fallen from 69% to 48% during same period; delays in patient recruitment for clinical trials account for an average of 4.6 months lost per trial – an annual cumulative loss of 26 years, on average, for each company; 80% of total trials are delayed at least one month because of unfulfilled enrollment.
The bottom line? Patient recruitment as we know it just isn't working.
This audio conference presentation looks at the efforts currently used to reach recruitment goals, why they are ineffective, and why new approaches must be implemented. Our speaker shares specific strategies that can be easily implemented, and helps attendees understand the patient's perspective and how to use that awareness to make recruitment plans more effective.
The numbers don't lie: clinical trial enrollment rates have dropped from 75% in 2000 to 59% in 2006 and retention rates have fallen from 69% to 48% during same period; delays in patient recruitment for clinical trials account for an average of 4.6 months lost per trial – an annual cumulative loss of 26 years, on average, for each company; 80% of total trials are delayed at least one month because of unfulfilled enrollment.
The bottom line? Patient recruitment as we know it just isn't working.
This audio conference presentation looks at the efforts currently used to reach recruitment goals, why they are ineffective, and why new approaches must be implemented. Our speaker shares specific strategies that can be easily implemented, and helps attendees understand the patient's perspective and how to use that awareness to make recruitment plans more effective.
Monday, January 9, 2012
An Overview of Recent Risk-based Monitoring Guidance from the FDA
is being presented by Dr. Joy Frestedt, President & CEO, of Frestedt Incorporated and airs on Wednesday, January 25th, 2012. For more details, or to register please visit our site at www.fxconferences.com
We have been waiting for an update on the FDA guidance on monitoring since 1988, and that update is finally here! This presentation reviews three FDA recent guidance documents about monitoring. Our speaker discusses the information provided in the 'Compliance Program Guidance Manual' for BIMO inspectors 'CHAPTER 48 – Bioresearch Monitoring' (CPGM 7348.810 for sponsors, CROs and monitors and CPGM 7348.811 for clinical investigators and sponsor-investigators) for foods, biologics, drugs and devices, which was implemented in March of 2011. The presentation also reviews the long-awaited 'Guidance for Industry: Oversight of Clinical Investigations – A Risk-Based Approach to Monitoring' which was released in August of 2011 to 'enhance human subject protection and the quality of clinical trial data.
These documents are designed to clearly articulate alternative practices for a “modern, risk-based approach” to monitoring, and attendees of this audio conference gain valuable insight on the changes, and the resulting opportunity to change the way monitoring is done in efforts to improve attention to human subject protection and high quality data.
We have been waiting for an update on the FDA guidance on monitoring since 1988, and that update is finally here! This presentation reviews three FDA recent guidance documents about monitoring. Our speaker discusses the information provided in the 'Compliance Program Guidance Manual' for BIMO inspectors 'CHAPTER 48 – Bioresearch Monitoring' (CPGM 7348.810 for sponsors, CROs and monitors and CPGM 7348.811 for clinical investigators and sponsor-investigators) for foods, biologics, drugs and devices, which was implemented in March of 2011. The presentation also reviews the long-awaited 'Guidance for Industry: Oversight of Clinical Investigations – A Risk-Based Approach to Monitoring' which was released in August of 2011 to 'enhance human subject protection and the quality of clinical trial data.
These documents are designed to clearly articulate alternative practices for a “modern, risk-based approach” to monitoring, and attendees of this audio conference gain valuable insight on the changes, and the resulting opportunity to change the way monitoring is done in efforts to improve attention to human subject protection and high quality data.
Friday, July 8, 2011
Global Clinical Trials & ISO 14155: 2011 Compliance - Are Your Quality Systems Up to Date
is being presented by Dr. Joy Frestedt, President & CEO, of Frestedt Incorporated and airs on Wednesday, August 10th, 2011. For more details or to register, please visit our site at www.fxconferences.com
Are your quality systems for clinical trials compliant with ISO 14155:2011 Clinical Investigations of Medical Devices for Human Subjects - Good Clinical Practices (2nd edition)?
ISO 14155 is an international standard designed to guide companies as they fulfill the many different regulatory requirements for international clinical trials. First issued in 2003, this 2011 update has attempted to unify many different standards for global clinical trials including requirements of the Global Harmonization Task Force, the International Conference on Harmonization Good Clinical Practice documents and some guidance information from the FDA. The goal of this work is to ensure clinical trial data generated anywhere in the world meets certain minimum standards. With over 65 pages of detailed requirements, ISO 14155:2011 now contains four administrative sections, three project management sections, two responsibilities sections and six annexes. Ensuring your systems are compliant with every component of this global standard is complicated work.
This presentation reviews the required elements to consider when conducting trials outside the United States, breaking the standard down into manageable parts and discussing how to integrate ISO 14155:2011 into your current clinical research quality system. The speaker provides a standard checklist to ensure your system/trials address all the required elements. This topic is especially timely, since the ISO 14155 standard was just released in January, 2011 and many companies are undergoing internal quality system updates to ensure their SOPs are compliant. This presentation is designed to make sure each member of the clinical, regulatory and quality teams fully understand what is included in ISO 14155 so they can be confident as they ensure all the parts of this essential standard are addressed in their day-to-day clinical trial activities. Participants will hear about the device-specific requirements of ISO 14155 including areas now harmonized with other standards, and get useful tips about how to navigate in-house quality system improvements designed to ensure compliance with the new ISO 14155: 2011 standard.
Are your quality systems for clinical trials compliant with ISO 14155:2011 Clinical Investigations of Medical Devices for Human Subjects - Good Clinical Practices (2nd edition)?
ISO 14155 is an international standard designed to guide companies as they fulfill the many different regulatory requirements for international clinical trials. First issued in 2003, this 2011 update has attempted to unify many different standards for global clinical trials including requirements of the Global Harmonization Task Force, the International Conference on Harmonization Good Clinical Practice documents and some guidance information from the FDA. The goal of this work is to ensure clinical trial data generated anywhere in the world meets certain minimum standards. With over 65 pages of detailed requirements, ISO 14155:2011 now contains four administrative sections, three project management sections, two responsibilities sections and six annexes. Ensuring your systems are compliant with every component of this global standard is complicated work.
This presentation reviews the required elements to consider when conducting trials outside the United States, breaking the standard down into manageable parts and discussing how to integrate ISO 14155:2011 into your current clinical research quality system. The speaker provides a standard checklist to ensure your system/trials address all the required elements. This topic is especially timely, since the ISO 14155 standard was just released in January, 2011 and many companies are undergoing internal quality system updates to ensure their SOPs are compliant. This presentation is designed to make sure each member of the clinical, regulatory and quality teams fully understand what is included in ISO 14155 so they can be confident as they ensure all the parts of this essential standard are addressed in their day-to-day clinical trial activities. Participants will hear about the device-specific requirements of ISO 14155 including areas now harmonized with other standards, and get useful tips about how to navigate in-house quality system improvements designed to ensure compliance with the new ISO 14155: 2011 standard.
Monday, May 9, 2011
Conducting Vendor Audits from an IT Perspective
is being presented by Terri Mead, President, of Solutions2Projects, LLC and airs on Wednesday, May 25th, 2011. For more details or to register, please visit our site at www.fxconferences.com
In the past, vendor audits were standard practice prior to the purchase of, or as part of validating, an IT system. As resources have gotten tighter and life sciences companies perhaps perceived less of a threat from the FDA on computer validation, many companies have moved away from performing vendor audits.
These days, FDA is scrutinizing IT systems, and has not overlooked the tendency with many companies to try and justify their way out of conducting vendor audits. This is true for both the outsourcing of processes to CROs and the implementation of IT systems on-site. With FDA’s focus on computer systems as part of PAIs and other inspections, ignoring vendor audits is a risk you can’t afford to take.
This audio conference presentation takes attendees through the elements of a vendor audit for both the purchase of software for a validated system, and for outsourcing of services that include IT systems such as clinical trial management.
In the past, vendor audits were standard practice prior to the purchase of, or as part of validating, an IT system. As resources have gotten tighter and life sciences companies perhaps perceived less of a threat from the FDA on computer validation, many companies have moved away from performing vendor audits.
These days, FDA is scrutinizing IT systems, and has not overlooked the tendency with many companies to try and justify their way out of conducting vendor audits. This is true for both the outsourcing of processes to CROs and the implementation of IT systems on-site. With FDA’s focus on computer systems as part of PAIs and other inspections, ignoring vendor audits is a risk you can’t afford to take.
This audio conference presentation takes attendees through the elements of a vendor audit for both the purchase of software for a validated system, and for outsourcing of services that include IT systems such as clinical trial management.
Friday, April 1, 2011
MEDDEV 2.7/3: Best Practices for Clinical Evaluation Reports
is being presented by Helen Colquhoun, CEO, of Pleiad Inc. and airs on Wednesday, May 4th, 2011. For more details, or to register please visit our site at www.fxconferences.com
Evaluation of clinical data is a necessary part of the European technical file or design dossier for CE marking of medical devices. The purpose of the evaluation is to demonstrate conformity with the essential requirements concerning performance and safety of the device under normal conditions of use. The data may come from published literature, clinical trials, or a combination of the two.
This audio conference will focus on the literature route for providing clinical data, which, if done well, may preclude the need for a de novo clinical trial. The presentation will highlight best practices, describe the Medical Device Directive (MDD) requirements concerning clinical evaluation, and describe the most recent changes in the regulatory guidance, MEDDEV 2.7/3, which was issued in December 2010.
Evaluation of clinical data is a necessary part of the European technical file or design dossier for CE marking of medical devices. The purpose of the evaluation is to demonstrate conformity with the essential requirements concerning performance and safety of the device under normal conditions of use. The data may come from published literature, clinical trials, or a combination of the two.
This audio conference will focus on the literature route for providing clinical data, which, if done well, may preclude the need for a de novo clinical trial. The presentation will highlight best practices, describe the Medical Device Directive (MDD) requirements concerning clinical evaluation, and describe the most recent changes in the regulatory guidance, MEDDEV 2.7/3, which was issued in December 2010.
Wednesday, March 16, 2011
Global Clinical Trials & ISO 14155 Compliance – Are You Ready to Update
is being presented by Dr. Joy Frestedt, President & CEO, of Frestedt Incorporated and airs on Wednesday, April 13th, 2011. For more details, or to register please visit our site at www.fxconferences.com
Are your quality systems for clinical trials compliant with ISO 14155? ISO 14155: The Clinical Investigation of Medical Devices for Human Subjects is an international standard designed to guide companies as they fulfill the regulatory requirements for international clinical trials. With over 30 pages of detailed required elements in Part 1: General Requirements and Part 2: The Clinical Investigation Plan, ensuring your systems are compliant with every component of the standard is complicated work.
This presentation reviews the required elements to consider when conducting trials outside the United States, breaking the standard down into manageable parts and discussing how to integrate ISO 14155 into your current clinical research quality system. The speaker provides a standard checklist to ensure your system/trials address all the required elements.
This presentation is especially timely, since the ISO 14155 standard has been undergoing revision to become more consistent with the Global Harmonization Task Force (GHTF) and the International Conference on Harmonization (ICH) Good Clinical Practice (GCP) documents, to ensure data generated anywhere in the world meets minimum standards.
This presentation is designed to make sure each member of the clinical team fully understands what is included in ISO 14155 so they can be confident as they ensure all the parts of this essential standard are addressed in their day- to-day clinical trial activities. Participants will hear about the device-specific requirements of ISO 14155 along with the clinical trial guidelines of the GHTF and the ICH GCPs, and useful tips on how to prepare for changes to in-house quality systems to ensure compliance with the new standards when they are released.
Are your quality systems for clinical trials compliant with ISO 14155? ISO 14155: The Clinical Investigation of Medical Devices for Human Subjects is an international standard designed to guide companies as they fulfill the regulatory requirements for international clinical trials. With over 30 pages of detailed required elements in Part 1: General Requirements and Part 2: The Clinical Investigation Plan, ensuring your systems are compliant with every component of the standard is complicated work.
This presentation reviews the required elements to consider when conducting trials outside the United States, breaking the standard down into manageable parts and discussing how to integrate ISO 14155 into your current clinical research quality system. The speaker provides a standard checklist to ensure your system/trials address all the required elements.
This presentation is especially timely, since the ISO 14155 standard has been undergoing revision to become more consistent with the Global Harmonization Task Force (GHTF) and the International Conference on Harmonization (ICH) Good Clinical Practice (GCP) documents, to ensure data generated anywhere in the world meets minimum standards.
This presentation is designed to make sure each member of the clinical team fully understands what is included in ISO 14155 so they can be confident as they ensure all the parts of this essential standard are addressed in their day- to-day clinical trial activities. Participants will hear about the device-specific requirements of ISO 14155 along with the clinical trial guidelines of the GHTF and the ICH GCPs, and useful tips on how to prepare for changes to in-house quality systems to ensure compliance with the new standards when they are released.
Tuesday, March 8, 2011
The Continuing Evolution of Clinical Research in India
is being presented by Dr. Vijai Kumar & Dan McDonald, President/Chief Medical Officer & Vice President Business Strategy, with Excel Life Sciences and airs on Tuesday, April 5th, 2011. For more details, or to register please visit our site at www.fxconferences.com
The continued growth of clinical research in India can be attributed to a number of factors. The regulatory environment has improved in recent years, as has the infrastructure and the level of experience. These, when combined with the never-ending quest to reduce drug development costs and timelines, have fueled an increase in the number of clinical trials in India. With that expansion has come a growing diversity in both the size and types of trials sponsors are seeking to conduct in the Indian market. In response to this diversification, the regulatory requirements continue to evolve, both in an official context and also through the views and opinions of the agency and how they are evaluating the submissions.
Though the market for clinical trials in India has improved dramatically, a number of complexities still exist and like most markets today, specifics in the regulatory guidelines, combined with regional and cultural intricacies make having an strong grasp on these elements critical. This audio conference presentation is designed to provide attendees with specific details regarding the regulatory guidelines that exist today in India, and where these regulations might be headed in the future.
The continued growth of clinical research in India can be attributed to a number of factors. The regulatory environment has improved in recent years, as has the infrastructure and the level of experience. These, when combined with the never-ending quest to reduce drug development costs and timelines, have fueled an increase in the number of clinical trials in India. With that expansion has come a growing diversity in both the size and types of trials sponsors are seeking to conduct in the Indian market. In response to this diversification, the regulatory requirements continue to evolve, both in an official context and also through the views and opinions of the agency and how they are evaluating the submissions.
Though the market for clinical trials in India has improved dramatically, a number of complexities still exist and like most markets today, specifics in the regulatory guidelines, combined with regional and cultural intricacies make having an strong grasp on these elements critical. This audio conference presentation is designed to provide attendees with specific details regarding the regulatory guidelines that exist today in India, and where these regulations might be headed in the future.
Tuesday, February 8, 2011
Safety Reporting for Clinical Trials
is being presented by Helen Colquhoun, CEO, of Pleiad Inc. and airs on Wednesday, March 9th, 2011. For more details or to register, please visit our site at www.fxconferences.com
This audio conference provides an overview of the rules for expedited and periodic safety reporting for clinical trials of drugs and medical devices in the EU and USA. It is relatively easy to be compliant in the harmonized world of pharmaceutical clinical trials. However, this contrasts with the disparate requirements for medical device studies.
In this presentation, our speaker reviews the regulations and guidance and explains what needs to be reported to the regulatory authority and ethics committee or IRB, and when. The presentation also explains the procedures that need to be in place to ensure compliance for safety reporting in complex situations such as trials that span different regions, or trials of products that are regulated differently in different territories. Other "hot button" topics are addressed as well. Attendees learn what needs to be reported when, and how to set up procedures that ensure compliance with safety reporting requirements, whether the clinical trial is a simple one or more complicated.
This audio conference provides an overview of the rules for expedited and periodic safety reporting for clinical trials of drugs and medical devices in the EU and USA. It is relatively easy to be compliant in the harmonized world of pharmaceutical clinical trials. However, this contrasts with the disparate requirements for medical device studies.
In this presentation, our speaker reviews the regulations and guidance and explains what needs to be reported to the regulatory authority and ethics committee or IRB, and when. The presentation also explains the procedures that need to be in place to ensure compliance for safety reporting in complex situations such as trials that span different regions, or trials of products that are regulated differently in different territories. Other "hot button" topics are addressed as well. Attendees learn what needs to be reported when, and how to set up procedures that ensure compliance with safety reporting requirements, whether the clinical trial is a simple one or more complicated.
Monday, December 13, 2010
Global Clinical Trials & ISO 14155 Compliance – Are You Ready to Update?
is being presented by Dr. Joy Frestedt, President & CEO, of Frestedt Incorporated and airs on Wednesday, January 19th, 2011. For more details or to register, please visit our site at www.fxconferences.com
Are your quality systems for clinical trials compliant with ISO 14155? ISO 14155: The Clinical Investigation of Medical Devices for Human Subjects is an international standard designed to guide companies as they fulfill the regulatory requirements for international clinical trials. With over 30 pages of detailed required elements in Part 1: General Requirements and Part 2: The Clinical Investigation Plan, ensuring your systems are compliant with every component of the standard is complicated work.
This presentation reviews the required elements to consider when conducting trials outside the United States, breaking the standard down into manageable parts and discussing how to integrate ISO 14155 into your current clinical research quality system. The speaker provides a standard checklist to ensure your system/trials address all the required elements.
This presentation is especially timely, since the ISO 14155 standard has been undergoing revision to become more consistent with the Global Harmonization Task Force (GHTF) and the International Conference on Harmonization (ICH) Good Clinical Practice (GCP) documents, to ensure data generated anywhere in the world meets minimum standards.
This presentation is designed to make sure each member of the clinical team fully understands what is included in ISO 14155 so they can be confident as they ensure all the parts of this essential standard are addressed in their day- to-day clinical trial activities. Participants will hear about the device-specific requirements of ISO 14155 along with the clinical trial guidelines of the GHTF and the ICH GCPs, and useful tips on how to prepare for changes to in-house quality systems to ensure compliance with the new standards when they are released.
Are your quality systems for clinical trials compliant with ISO 14155? ISO 14155: The Clinical Investigation of Medical Devices for Human Subjects is an international standard designed to guide companies as they fulfill the regulatory requirements for international clinical trials. With over 30 pages of detailed required elements in Part 1: General Requirements and Part 2: The Clinical Investigation Plan, ensuring your systems are compliant with every component of the standard is complicated work.
This presentation reviews the required elements to consider when conducting trials outside the United States, breaking the standard down into manageable parts and discussing how to integrate ISO 14155 into your current clinical research quality system. The speaker provides a standard checklist to ensure your system/trials address all the required elements.
This presentation is especially timely, since the ISO 14155 standard has been undergoing revision to become more consistent with the Global Harmonization Task Force (GHTF) and the International Conference on Harmonization (ICH) Good Clinical Practice (GCP) documents, to ensure data generated anywhere in the world meets minimum standards.
This presentation is designed to make sure each member of the clinical team fully understands what is included in ISO 14155 so they can be confident as they ensure all the parts of this essential standard are addressed in their day- to-day clinical trial activities. Participants will hear about the device-specific requirements of ISO 14155 along with the clinical trial guidelines of the GHTF and the ICH GCPs, and useful tips on how to prepare for changes to in-house quality systems to ensure compliance with the new standards when they are released.
Monday, December 6, 2010
Enhanced Monitoring Tools and Strategies to Optimize Productivity and Compliance
is being presented by Kimberly Kiner, President, of 2K Clinical Consulting and airs on Tuesday, January 11th, 2011. For more details or to register, please visit our site at www.fxconferences.com
Clinical monitoring represents a crucial aspect of clinical research trials in ensuring subject safety, data integrity, and proper trial conduct in Good Clinical Practice (GCP) compliance and other regulations. Typically, a clinical research associate (CRA) who has mastered basic monitoring can be effective in ensuring site compliance. However, as the complexity of clinical research trials increases and timelines shorten, there is a need for more efficient monitoring practices. This presentation discusses the issues surrounding monitoring performance in US-based pre-market studies and provides enhanced techniques to optimize productivity without compromising subject safety and quality of data.
Clinical monitoring represents a crucial aspect of clinical research trials in ensuring subject safety, data integrity, and proper trial conduct in Good Clinical Practice (GCP) compliance and other regulations. Typically, a clinical research associate (CRA) who has mastered basic monitoring can be effective in ensuring site compliance. However, as the complexity of clinical research trials increases and timelines shorten, there is a need for more efficient monitoring practices. This presentation discusses the issues surrounding monitoring performance in US-based pre-market studies and provides enhanced techniques to optimize productivity without compromising subject safety and quality of data.
Friday, October 15, 2010
Academic Medical Centers and Clinical Research Productivity: How to Choose The Best Sites
is being presented by Anita S. Kablinger, Physician, Carilion Clinic
, Virginia Tech Carilion School of Medicine and airs on Tuesday, November 23rd, 2010. For more details or to register, please visit our site at www.fxconferences.com
Fulfilling enrollment numbers for clinical trials and providing the required data is of utmost concern to industry. Subject selection must be accurate and swift to meet deadlines. Recruitment remains one of the most difficult aspects of clinical research and choosing sites that will produce good clinical data of truly ill patients is always hard. Literature suggests that, although private research sites often achieve enrollment numbers in a timely fashion, academic center subject selection frequently represents sicker patients with a subsequent lower placebo response. How then does industry and its partners determine the appropriate sites for a multi-center trial to achieve success?
This presentation reviews the important aspects of site selection with respect to academic medical centers, with the goal of maximizing efficiency and productivity of all those involved and increasing the probability of study success.
, Virginia Tech Carilion School of Medicine and airs on Tuesday, November 23rd, 2010. For more details or to register, please visit our site at www.fxconferences.com
Fulfilling enrollment numbers for clinical trials and providing the required data is of utmost concern to industry. Subject selection must be accurate and swift to meet deadlines. Recruitment remains one of the most difficult aspects of clinical research and choosing sites that will produce good clinical data of truly ill patients is always hard. Literature suggests that, although private research sites often achieve enrollment numbers in a timely fashion, academic center subject selection frequently represents sicker patients with a subsequent lower placebo response. How then does industry and its partners determine the appropriate sites for a multi-center trial to achieve success?
This presentation reviews the important aspects of site selection with respect to academic medical centers, with the goal of maximizing efficiency and productivity of all those involved and increasing the probability of study success.
Wednesday, September 22, 2010
Adapting Project Risk Mitigation and Prevention Tools in Real-Life Trials
is being presented by Susan Schenk, Clinical Development Services, Director, Operational Strategy & Planning, with Covance Inc. and airs on Thursday, October 14th, 2010. For more details or to register for this event, please visit our site at www.fxconferences.com
Managing and preventing risk is an integral part of clinical trial conduct in order to achieve high-quality data on time and on budget. However, industry data reveals that a large percentage of clinical trial budgets is allocated towards remediation, focused on fixing problems after they occur, rather than towards proactive activities to help predict and prevent costly errors. This audio conference showcases a complementary range of real-life examples of how to leverage sophisticated tools such as Failure Modes & Effects Analysis (FMEA) to proactively manage project-related risk.
However, in the project management arena, there is often a gap between the sophisticated tools and proactive approaches available to manage project-related risk, and the general level of understanding of how to deploy these tools.
Specifically addressing this issue, the audio conference aims to help close the gap by exploring a number of different ways to leverage theory into practice. Acknowledging the need for continuous mitigation of project-related risks, the speaker also demonstrates methods to overcome challenges that may occur mid-study, successfully absorbing and minimizing the impact to timelines and resources.
Managing and preventing risk is an integral part of clinical trial conduct in order to achieve high-quality data on time and on budget. However, industry data reveals that a large percentage of clinical trial budgets is allocated towards remediation, focused on fixing problems after they occur, rather than towards proactive activities to help predict and prevent costly errors. This audio conference showcases a complementary range of real-life examples of how to leverage sophisticated tools such as Failure Modes & Effects Analysis (FMEA) to proactively manage project-related risk.
However, in the project management arena, there is often a gap between the sophisticated tools and proactive approaches available to manage project-related risk, and the general level of understanding of how to deploy these tools.
Specifically addressing this issue, the audio conference aims to help close the gap by exploring a number of different ways to leverage theory into practice. Acknowledging the need for continuous mitigation of project-related risks, the speaker also demonstrates methods to overcome challenges that may occur mid-study, successfully absorbing and minimizing the impact to timelines and resources.
Tuesday, September 14, 2010
Successful Vendor Management in Clinical Trials
is being presented by Laurie Halloran, President and CEO, of Halloran Consulting Group, Inc. and airs on Wednesday, October 20th, 2010. For more details or to register, please visit our site at www.fxconferences.com
Effective management of outsourced clinical programs is a critical skill in companies that use external vendors to provide the required services for conducting clinical trials. But why does a sponsor need to monitor a CRO, and what are the best methods to ensure adequate oversight? What best practices should companies follow to ensure quality and consistency of outsourced operational work? This audio conference discusses the essential knowledge and skills required to identify, qualify, select, set and manage expectations of vendors throughout clinical projects of all sizes.
Effective management of outsourced clinical programs is a critical skill in companies that use external vendors to provide the required services for conducting clinical trials. But why does a sponsor need to monitor a CRO, and what are the best methods to ensure adequate oversight? What best practices should companies follow to ensure quality and consistency of outsourced operational work? This audio conference discusses the essential knowledge and skills required to identify, qualify, select, set and manage expectations of vendors throughout clinical projects of all sizes.
Wednesday, September 1, 2010
Feasibility: Laying The Foundation for a Successful Clinical Trial
is being presented by Kim Nelson, Director, Global Feasibility Strategy, with PPD and airs on Wednesday, October 6th, 2010. For more details or to register, please visit our site at www.fxconferences.com
Clinical trial enrollment delays are common and can lead to increased study costs and extended time to market. A formal feasibility performed early in the development process can guide the project team through scenario planning that allows for more accurate planning.
By combining study-specific information collected through surveys or interviews with historical data from prior studies and other data sources, teams are able to make more informed enrollment projections that can aid in operational planning. These enrollment projections should then be combined with other relevant data such as insurance reimbursement, the regulatory environment, enthusiasm for the study therapy, regional differences or shifts in patterns of care and potential operational challenges to make country- and site-level recommendations. This presentation focuses on the steps of proper planning through a robust feasibility assessment to guide successful clinical trial completion.
Clinical trial enrollment delays are common and can lead to increased study costs and extended time to market. A formal feasibility performed early in the development process can guide the project team through scenario planning that allows for more accurate planning.
By combining study-specific information collected through surveys or interviews with historical data from prior studies and other data sources, teams are able to make more informed enrollment projections that can aid in operational planning. These enrollment projections should then be combined with other relevant data such as insurance reimbursement, the regulatory environment, enthusiasm for the study therapy, regional differences or shifts in patterns of care and potential operational challenges to make country- and site-level recommendations. This presentation focuses on the steps of proper planning through a robust feasibility assessment to guide successful clinical trial completion.
Friday, August 13, 2010
Using Local Laboratory Data in Phase II and III Pivotal Studies
is being presented by Jaap H.M. Dijkman, CEO, of Medial NL and airs on Thursday, September 23rd, 2010. For more details or to register please visit our site at www.fxconferences.com
Many pivotal studies rely on local laboratory data for their endpoints, either as standalone lab data or in conjunction with central laboratory data. But what limitations do local laboratory data have in terms of quality and variability? And how easy or difficult is it to collect them? This audio conference presentation provides comparisons between central and local laboratory data in terms of quality and combinability, and gives attendees valuable insight into choosing the right design for their clinical trials.
Many pivotal studies rely on local laboratory data for their endpoints, either as standalone lab data or in conjunction with central laboratory data. But what limitations do local laboratory data have in terms of quality and variability? And how easy or difficult is it to collect them? This audio conference presentation provides comparisons between central and local laboratory data in terms of quality and combinability, and gives attendees valuable insight into choosing the right design for their clinical trials.
Thursday, July 22, 2010
Adapting Project Risk Mitigation and Prevention Tools in Real-Life Trials
is being presented by Susan Schenk, Clinical Development Services, Director, Operational Strategy & Planning, with Covance Inc. and airs on Tuesday, September 21st, 2010. For more details or to register for this event, please visit our site at www.fxconferences.com
Managing and preventing risk is an integral part of clinical trial conduct in order to achieve high-quality data on time and on budget. However, industry data reveals that a large percentage of clinical trial budgets is allocated towards remediation, focused on fixing problems after they occur, rather than towards proactive activities to help predict and prevent costly errors. This audio conference showcases a complementary range of real-life examples of how to leverage sophisticated tools such as Failure Modes & Effects Analysis (FMEA) to proactively manage project-related risk.
However, in the project management arena, there is often a gap between the sophisticated tools and proactive approaches available to manage project-related risk, and the general level of understanding of how to deploy these tools.
Specifically addressing this issue, the audio conference aims to help close the gap by exploring a number of different ways to leverage theory into practice. Acknowledging the need for continuous mitigation of project-related risks, the speaker also demonstrates methods to overcome challenges that may occur mid-study, successfully absorbing and minimizing the impact to timelines and resources.
Managing and preventing risk is an integral part of clinical trial conduct in order to achieve high-quality data on time and on budget. However, industry data reveals that a large percentage of clinical trial budgets is allocated towards remediation, focused on fixing problems after they occur, rather than towards proactive activities to help predict and prevent costly errors. This audio conference showcases a complementary range of real-life examples of how to leverage sophisticated tools such as Failure Modes & Effects Analysis (FMEA) to proactively manage project-related risk.
However, in the project management arena, there is often a gap between the sophisticated tools and proactive approaches available to manage project-related risk, and the general level of understanding of how to deploy these tools.
Specifically addressing this issue, the audio conference aims to help close the gap by exploring a number of different ways to leverage theory into practice. Acknowledging the need for continuous mitigation of project-related risks, the speaker also demonstrates methods to overcome challenges that may occur mid-study, successfully absorbing and minimizing the impact to timelines and resources.
Monday, July 12, 2010
Selecting a Phase I Clinical Trial Site
is being presented by Lorraine S. DeCesare, President, with LS Drug Development, Inc. and airs on Tuesday, August 17th, 2010. For more details or to register, please visit our site at www.fxconferences.com
Phase I clinical trials are a critical step in the development program for an investigational product. First-in-man studies are the first step in the development program, but bioequivalency studies and food effect studies can also make or break the life cycle of an investigational product. Phase I studies are very different from Phase II-IV studies; all subjects in a Phase I study participate at the same time and at the time scheduled by the site, whereas in Phase III studies each subject participates on his own schedule. All activities in a Phase I study are conducted relative to the time of dosing and are usually minutes rather than days or even weeks apart as in Phase III studies.
This audio conference discusses the critical areas in selection of a clinical trial site for the conduct of Phase I studies, be they complex first-in-man studies or more routine bioequivalence studies.
Phase I clinical trials are a critical step in the development program for an investigational product. First-in-man studies are the first step in the development program, but bioequivalency studies and food effect studies can also make or break the life cycle of an investigational product. Phase I studies are very different from Phase II-IV studies; all subjects in a Phase I study participate at the same time and at the time scheduled by the site, whereas in Phase III studies each subject participates on his own schedule. All activities in a Phase I study are conducted relative to the time of dosing and are usually minutes rather than days or even weeks apart as in Phase III studies.
This audio conference discusses the critical areas in selection of a clinical trial site for the conduct of Phase I studies, be they complex first-in-man studies or more routine bioequivalence studies.
Thursday, June 24, 2010
The Future of Clinical Trial Site and Patient Recruitment Is Here
is being presented by Kent Tholke, Senior Vice President, Scientific and Medical Affairs, with PRA International and airs on Thursday, July 22nd, 2010. For more details or to register, please visit our site at www.fxconferences.com
The key to successful site and patient recruitment is having the ability to mine electronic health records as well as pharmacy, claims, laboratory and historical CRO recruitment data using proprietary search algorithms. Current research indicates that more than 25% of clinical trial sites are unproductive. Relying on a data-driven decision making process will lead to far fewer non-productive clinical trial sites, shorter development timelines, greater patient recruitment and ultimately lower drug development costs.
With more clinical trials being conducted — and with the majority of them operating under delayed timelines — patient access has become the critical piece to solving what has become a very inefficient and costly puzzle known as drug development. While the process of drug development over the last few decades has been heavily driven by scientific methodology, the process by which clinical trials are conducted has consistently lacked the same rigor. Achieving successful patient access and meeting clinical trial timelines will require CROs to use more accurate processes for site selection and targeted patient enrollment.
Although having access to relevant data is important to enhancing site selection and patient recruitment, sponsors and CROs must also mine this data with algorithms that have been established to match planned patient populations and inclusion/exclusion criteria. When sponsors and CROs apply detailed search algorithms across multiple patient data platforms, they are able to find and target sites with the appropriate patient populations and confirm that the planned trial design matches customary care practices. This confirmation is the first step to both determining a trial’s feasibility and mining patient data. In addition, sponsor companies can use data-mining algorithms to determine if medical professionals are treating the target patient population as expected and to locate the patients by physician practice.
This audio conference explores the power of mining EHR/EMR, lab, pharmacy, claims and historical CRO recruitment data. It will also review how using data-driven decision making to validate trial designs and patient and site selection is a key to successful drug development.
The key to successful site and patient recruitment is having the ability to mine electronic health records as well as pharmacy, claims, laboratory and historical CRO recruitment data using proprietary search algorithms. Current research indicates that more than 25% of clinical trial sites are unproductive. Relying on a data-driven decision making process will lead to far fewer non-productive clinical trial sites, shorter development timelines, greater patient recruitment and ultimately lower drug development costs.
With more clinical trials being conducted — and with the majority of them operating under delayed timelines — patient access has become the critical piece to solving what has become a very inefficient and costly puzzle known as drug development. While the process of drug development over the last few decades has been heavily driven by scientific methodology, the process by which clinical trials are conducted has consistently lacked the same rigor. Achieving successful patient access and meeting clinical trial timelines will require CROs to use more accurate processes for site selection and targeted patient enrollment.
Although having access to relevant data is important to enhancing site selection and patient recruitment, sponsors and CROs must also mine this data with algorithms that have been established to match planned patient populations and inclusion/exclusion criteria. When sponsors and CROs apply detailed search algorithms across multiple patient data platforms, they are able to find and target sites with the appropriate patient populations and confirm that the planned trial design matches customary care practices. This confirmation is the first step to both determining a trial’s feasibility and mining patient data. In addition, sponsor companies can use data-mining algorithms to determine if medical professionals are treating the target patient population as expected and to locate the patients by physician practice.
This audio conference explores the power of mining EHR/EMR, lab, pharmacy, claims and historical CRO recruitment data. It will also review how using data-driven decision making to validate trial designs and patient and site selection is a key to successful drug development.
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